DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 144 in Fig. 4 (which appears to correspond with drain 114 mentioned in the description).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the fluid channel fluidly coupling a bottom end of the first fluid column to a bottom end of the second fluid column (as recited in claims 1 and 11; examiner notes that Fig. 4 appears to show the bottom end of the second fluid column 106 coupled to the pump 34, and the connection between first fluid column 102, fluid manifold 112, and second fluid column 106 is unclear) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 11 recite the limitations “the second internal volume of fluid” and “the second volume of fluid.” There is insufficient antecedent basis for these limitations in the claims. For examination purposes, these claims will be read as wherein the second fluid column is adapted to generate a siphon for drawing fluid out of the second hose as a volume of fluid in the second fluid column is pulled downward by gravity. Dependent claims 2-10 and 12-20 are necessarily rejected as depending upon rejected base claims.
Claim 3 does not recite a claim dependency, which renders the scope of the claim unclear. For examination purposes, this claim will be read as depending upon claim 1.
Claim 10 recites the limitation “the air” in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be read as --the ambient air--.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hopper et al. (US PGPub No. 2014/0343639), hereinafter Hopper, in view of Henderson (US Patent No. 2,486,405) and further in view of Dabrowiak et al. (US PGPub No. 2018/0214302), hereinafter Dabrowiak.
Regarding claim 1, Hopper teaches a thermal control unit for controlling a patient’s temperature during a thermal therapy session (Figs. 1-2: thermal control unit 22), the thermal control unit comprising:
a first fluid port adapted to fluidly couple to a first hose (Figs. 1 and 4: fluid inlet port 26 connected to return line 30b);
a second fluid port adapted to fluidly couple to a second hose (Fig. 4: fluid outlet port 24 connected to supply line 30a);
a first fluid column having a top end fluidly coupled to the first fluid port, the first fluid column including a first internal volume; and a second fluid column having a top end fluidly coupled to the second fluid port, the second fluid column having a second internal volume (Figs. 5 and 10: pump inlet and outlet tubes 106 and 108);
a pump for pumping fluid through the thermal control unit (Fig. 5: pump 52);
a heat exchanger adapted to add or remove heat from the fluid (Fig. 5: heat exchanger 58);
a fluid temperature sensor adapted to sense a temperature of the fluid (Fig. 5: fluid temperature sensors 74);
a patient temperature sensor port adapted to receive patient temperature readings from a patient temperature sensor (Figs. 1 and 4: patient temperature probe ports 28);
and a controller adapted to control the heat exchanger in order to control the patient's temperature (Fig. 5: controller 72; par. 0054: “control unit 22 does not necessarily adjust the temperature of the circulating fluid to maintain a constant temperature, but instead makes the necessary temperature adjustments to the fluid in order to effectuate the desired patient temperature”).
Hopper teaches using gravity to drain the fluid out of control unit 22 (par. 0074: “Any fluid within thermal pads 32 will also return to the lower regions of circulating channel 54 provided the pads 32 are positioned at a height that is greater than the height of inlet ports 26 so that gravity may pull the fluid downward out of the pads 32 and through inlet ports 26. […] In order to more completely remove the fluid from circulating channel 54, a drain 92 (FIG. 6) can be opened to further drain the fluid out of control unit 22”) but does not explicitly teach a second internal volume greater than the first internal volume and a fluid channel fluidly coupling a bottom end of the first fluid column to a bottom end of the second fluid column, wherein the second fluid column is adapted to generate a siphon for drawing fluid out of the second hose as a volume of fluid in the second fluid column is pulled downward by gravity. However, in an analogous art, Henderson teaches a method of draining a reservoir using first and second fluid columns with unequal internal volumes and fluidly coupled at their respective bottom ends (Figs. 1 and 2: first fluid column as upright branch 34 with open upper end, second fluid column as upright branch 35 with flexible tubing 50 and 41, connected by horizontal connecting tube 36) to generate a siphon for drawing fluid out of the reservoir as a volume of fluid in the second fluid column is pulled downward by gravity (col 4, lines 25-40: “negative pressure is established in the end 52 of the flexible tubing 50 which will either lift the column of solution in the vertical branch tube 35, or will draw the solution from the bladder. Since it is easier to siphon liquid from a reservoir closer to the force of negative pressure (as the solution in the bladder) than to lift a column of liquid against gravity (as the column of solution in the vertical branch tube 35), the bladder is emptied first, while the solution in the vertical branch tube 35 acts as an air lock. Only after the bladder is completely empty will the column of solution in the vertical branch tube 35 be lifted”).
To provide the thermal control unit of Hopper with the siphon mechanism taught by Henderson would have been obvious, before the effective filing date of the claimed invention, for the following reasons:
Hopper discloses a prior art fluid-manipulating medical device upon which the claimed invention (using a siphon for draining fluid from the system) can be seen as an “improvement” (Hopper discloses only direct gravitational drainage methods). Henderson teaches a prior art comparable device (a fluid-manipulating medical device) having a siphon for draining fluid out of a reservoir, which allows fluid to be drained without relying on positioning system components for gravity draining.
Thus, the manner of enhancing a particular device (fluid-manipulating medical device) was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in Henderson. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art medical device of Hopper and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have readily recognized that using a siphon to drain fluid from Hopper’s system would provide the ability to drain without positioning the system components for gravity draining.
Henderson teaches an open upper end for the first fluid column and does not teach a return valve adapted to allow ambient air to enter the first fluid column when the return valve is opened and fluid is drained from the thermal control unit. However, in an analogous art, Dabrowiak teaches using a vent valve to control fluid drainage behavior from a medical thermal device (par. 0087: “To drain the body surface heat exchange device, the vent valve is opened which allows air into the circuit and prevents fluid from flowing from the bypass valve. This forces fluid out of the body surface heat exchange device to the pump”). In light of the teachings of Dabrowiak, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that applying the known technique taught by Dabrowiak (using a vent valve to selectively prohibit or allow ambient air to enter the fluid system) to the thermal control unit of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system wherein the siphoning behavior for draining fluid from the system can be controllably started using a vent valve rather than leaving the system always open to ambient air.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Hopper further teaches wherein the first fluid port is a fluid inlet adapted to receive fluid from the first hose when the pump is activated, and the second fluid port is a fluid outlet adapted to supply fluid to the second hose when the pump is activated (Fig. 1: first fluid ports 26 receiving fluid from return lines 30b, second fluid ports 24 supplying fluid to supply lines 30a).
Regarding claim 3, the combination teaches the device of claim 1 as described previously. Hopper in view of Henderson further teaches further including a drain positioned at a lower height than the fluid channel and in fluid communication with the fluid channel (Hopper at Figs. 6 and 10: drain 92; Henderson at Fig. 2 and col 3, lines 43-44: “The outlet of the end 53 of the tubing 50 is at a lower level than the U-tube 34, 35 and 36”), the drain adapted to be manually opened and closed by a user (par. 0074: “a drain 92 (FIG. 6) can be opened to further drain the fluid out of control unit 22”).
Regarding claim 4, the combination teaches the device of claim 3 as described previously. The combination is silent with respect to the type of valve used and does not explicitly teach wherein said return valve is a pressure activated valve adapted to automatically open after the drain is manually opened and fluid begins draining from the fluid channel.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the combined reference by using a pressure-activated valve rather than a manual one, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claim 5, the combination teaches the device of claim 4 as described previously. Henderson (in view of Dabrowiak) further teaches wherein the return valve is positioned adjacent the top end of the first fluid column (Fig. 1: upright branch 34 open to ambient air at its top end).
Regarding claim 9, the combination teaches the device of claim 1 as described previously. Hopper further teaches further comprising a fluid manifold positioned within the fluid system between the first and second fluid columns, and an air separator fluidly coupled to the fluid manifold, the air separator adapted to vent air from within the fluid manifold to ambient surroundings (0061: “Inlet manifold 64 includes the plurality of inlet ports 26 that receive fluid returning from the one or more connected thermal pads 32. The incoming fluid from inlet ports 26, as well as the fluid passing through bypass line 62, travels back toward the pump 52 into an air separator 68. Air separator 68 includes a generally vertical tube that is open at its top end to atmospheric pressure. Any air bubbles that are entrained in the circulating fluid will naturally rise up through air separator 68 and be vented to the atmosphere”).
Claims 6-8 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hopper in view of Henderson and Dabrowiak and further in view of Schock et al. (US PGPub No. 2006/0069418), hereinafter Schock.
Regarding claims 6-8, Hopper in view of Henderson and Dabrowiak teaches the device of claim 5 as described previously. The combination does not teach further comprising a supply valve positioned adjacent the top end of the second fluid column, said supply valve having a cracking pressure higher than the return valve, wherein the supply valve is adapted to allow ambient air to enter the second fluid column when the supply valve is opened and fluid is drained from the thermal control unit, wherein the supply valve is adapted to automatically open after the return valve opens. However, in an analogous art, Schock teaches a thermal therapy device with a siphon for draining heat transfer liquid (Fig. 3: siphon 82) comprising a valve positioned adjacent its top end (Fig. 3: vent 84) wherein the supply valve is adapted to allow ambient air to enter the second fluid column when the supply valve is opened and fluid is drained from the siphon (par. 0064: “A vent 84 is positioned on the tube 82 to provide an air break to thereby prevent siphoning of the heat transfer liquid 18 from the enclosure 14. The vent 84 can be selectively closed to facilitate siphoning, which may be advantageous when the heat transfer liquid 18 is being exhausted from the enclosure 14”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with a vent valve at the top of the second fluid column, as taught by Schock, since one of ordinary skill in the art would have recognized that applying the known technique taught by Shcok (using a vent to selectively prohibit or allow ambient air to enter the fluid system) to the thermal control unit of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system wherein the siphoning behavior for draining fluid from the system can be controllably stopped using a vent valve.
The combination is silent with respect to the type of valve and does not explicitly teach wherein the supply valve has a cracking pressure higher than the return valve such that the supply valve is adapted to automatically open after the return valve opens. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a pressure-activated valve for the supply valve that can be automatically opened after the return valve opens (that is, to stop the siphoning behavior after it has been activated), since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claim 11, Hopper in view of Henderson and Dabrowiak and further in view of Schock teaches the limitations of the claim for the same reasons previously set forth in the rejection of claim 7.
Regarding claims 12-14, 18, and 20, the combination teaches the device of claim 11 as described previously. The limitations for these claims are rejected for the same reasons previously set forth in the rejection of claims 6 and 8.
Regarding claim 15, the combination teaches the device of claim 11 as described previously. The limitations of this claim are rejected for the same reasons previously set forth in the rejection of claim 3.
Regarding claim 16, the combination teaches the device of claim 15 as described previously. The limitations of this claim are rejected for the same reasons previously set forth in the rejection of claim 4.
Regarding claim 17, the combination teaches the device of claim 11 as described previously. The limitations of this claim are rejected for the same reasons previously set forth in the rejection of claim 9.
Regarding claim 19, the combination teaches the device of claim 11 as described previously. The limitations of this claim are rejected for the same reasons previously set forth in the rejection of claim 5.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hopper in view of Henderson and Dabrowiak and further in view of Landy, III et al. (US PGPub No. 2020/0001022), hereinafter Landy.
Hopper in view of Henderson and Dabrowiak teaches the device of claim 1 as described previously. The combination does not explicitly teach further comprising an air filter in fluid communication with the return valve and adapted to filter the ambient air that enters the first fluid column through the return valve. However, in a related medical device art, Landy teaches a valve for introducing air into a fluid system (par. 0159: “a fluid heating system that includes a vacuum release valve to prevent the undesired orientation of the deformed inflow tubing. In certain embodiments, the vacuum release valve supplies air to the tubing to reduce pressure difference between the inflow tubing and the surroundings”) comprising an air filter in fluid communication with the valve and adapted to filter the ambient air that enters the system through the valve, which provides sterile air to the system (par. 0163: “the vacuum release valve comprises a filter, and/or a sanitation unit to provide sterile air to the system”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by including an air filter, as taught by Landy, in order to provide sterile air to the system, as taught by Landy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./ Examiner, Art Unit 3794
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